Safety of abatacept compared with other biologic and conventional synthetic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis: data from an observational study
Identifieur interne : 000444 ( Main/Exploration ); précédent : 000443; suivant : 000445Safety of abatacept compared with other biologic and conventional synthetic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis: data from an observational study
Auteurs : Gulsen Ozen [États-Unis] ; Sofia Pedro [États-Unis] ; Rebecca Schumacher [États-Unis] ; Teresa A. Simon [États-Unis] ; Kaleb Michaud [États-Unis]Source :
- Arthritis Research & Therapy [ 1478-6354 ] ; 2019.
Abstract
To assess the risks of malignancies, infections and autoimmune diseases in patients with rheumatoid arthritis (RA) treated with abatacept compared with other biologic (b) disease-modifying antirheumatic drugs (DMARDs) or conventional synthetic (cs)DMARDs, in a US-wide observational RA cohort
Data were reviewed from patients (≥ 18 years) with RA who were registered with FORWARD, the National Databank for Rheumatic Diseases, and who initiated abatacept, other bDMARDs or csDMARDs between 2005 and 2015. Patients who switched treatment during the study could be allocated to more than one group. The incidence rates (IRs) by treatment were calculated for malignancies, hospitalized infections and autoimmune diseases identified by six monthly questionnaires and medical records. The hazard ratios (HRs) (95% confidence intervals [CIs]) for all outcomes with abatacept compared with other bDMARDs or csDMARDs were determined using marginal structural models adjusted for clinical confounders.
In the study sample, 1496 initiated abatacept, 3490 initiated another bDMARD and 1520 initiated a csDMARD. The risk of malignancies with abatacept was not statistically significant versus other bDMARDs (HR [95% CI)] 1.89 [0.93, 3.84]) or versus csDMARDs (HR [95% CI] 0.93 [0.20, 4.27]). Patients receiving abatacept versus other bDMARDs were at a lower risk of hospitalized infections (HR [95% CI] 0.37 [0.18, 0.75]); the risk versus csDMARDs was lower with wide CIs (HR [95% CI] 0.31 [0.09, 1.05]). The relative risks for psoriasis were similar between treatment groups (HR [95% CI] 1.46 [0.76, 2.81] and HR [95% CI] 2.05 [0.59, 7.16] for abatacept versus other bDMARDs and versus csDMARDS, respectively). The IR (95% CI) of severe infusion/injection reactions was lower with abatacept compared with other bDMARDs (1.57 [1.11, 2.17] vs 2.31 [1.87, 2.82] per 100 patient-years, respectively).
In this analysis, abatacept was well tolerated and did not result in an overall increased risk of malignancies, infections or autoimmune diseases compared with other bDMARDs or csDMARDs.
The online version of this article (10.1186/s13075-019-1921-z) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1186/s13075-019-1921-z
PubMed: 31174592
PubMed Central: 6555014
Affiliations:
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Simon</name><affiliation wicri:level="2"><nlm:aff id="Aff3"><institution-wrap><institution-id institution-id-type="GRID">grid.419971.3</institution-id><institution>Bristol-Myers Squibb,</institution></institution-wrap>Princeton, NJ USA</nlm:aff><country>États-Unis</country><placeName><region type="state">New Jersey</region></placeName><wicri:cityArea>Princeton</wicri:cityArea></affiliation></author><author><name sortKey="Michaud, Kaleb" sort="Michaud, Kaleb" uniqKey="Michaud K" first="Kaleb" last="Michaud">Kaleb Michaud</name><affiliation wicri:level="2"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 0666 4105</institution-id><institution-id institution-id-type="GRID">grid.266813.8</institution-id><institution>University of Nebraska Medical Center,</institution></institution-wrap>Omaha, NE USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Nebraska</region></placeName><wicri:cityArea>Omaha</wicri:cityArea></affiliation><affiliation wicri:level="2"><nlm:aff id="Aff2">FORWARD, The National Databank for Rheumatic Diseases, Wichita, KS USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Kansas</region></placeName><wicri:cityArea>FORWARD, The National Databank for Rheumatic Diseases, Wichita</wicri:cityArea></affiliation></author></analytic><series><title level="j">Arthritis Research & Therapy</title><idno type="ISSN">1478-6354</idno><idno type="eISSN">1478-6362</idno><imprint><date when="2019">2019</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p id="Par1">To assess the risks of malignancies, infections and autoimmune diseases in patients with rheumatoid arthritis (RA) treated with abatacept compared with other biologic (b) disease-modifying antirheumatic drugs (DMARDs) or conventional synthetic (cs)DMARDs, in a US-wide observational RA cohort</p></sec><sec><title>Methods</title><p id="Par2">Data were reviewed from patients (≥ 18 years) with RA who were registered with FORWARD, the National Databank for Rheumatic Diseases, and who initiated abatacept, other bDMARDs or csDMARDs between 2005 and 2015. Patients who switched treatment during the study could be allocated to more than one group. The incidence rates (IRs) by treatment were calculated for malignancies, hospitalized infections and autoimmune diseases identified by six monthly questionnaires and medical records. The hazard ratios (HRs) (95% confidence intervals [CIs]) for all outcomes with abatacept compared with other bDMARDs or csDMARDs were determined using marginal structural models adjusted for clinical confounders.</p></sec><sec><title>Results</title><p id="Par3">In the study sample, 1496 initiated abatacept, 3490 initiated another bDMARD and 1520 initiated a csDMARD. The risk of malignancies with abatacept was not statistically significant versus other bDMARDs (HR [95% CI)] 1.89 [0.93, 3.84]) or versus csDMARDs (HR [95% CI] 0.93 [0.20, 4.27]). Patients receiving abatacept versus other bDMARDs were at a lower risk of hospitalized infections (HR [95% CI] 0.37 [0.18, 0.75]); the risk versus csDMARDs was lower with wide CIs (HR [95% CI] 0.31 [0.09, 1.05]). The relative risks for psoriasis were similar between treatment groups (HR [95% CI] 1.46 [0.76, 2.81] and HR [95% CI] 2.05 [0.59, 7.16] for abatacept versus other bDMARDs and versus csDMARDS, respectively). The IR (95% CI) of severe infusion/injection reactions was lower with abatacept compared with other bDMARDs (1.57 [1.11, 2.17] vs 2.31 [1.87, 2.82] per 100 patient-years, respectively).</p></sec><sec><title>Conclusions</title><p id="Par4">In this analysis, abatacept was well tolerated and did not result in an overall increased risk of malignancies, infections or autoimmune diseases compared with other bDMARDs or csDMARDs.</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (10.1186/s13075-019-1921-z) contains supplementary material, which is available to authorized users.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Lacaille, D" uniqKey="Lacaille D">D Lacaille</name></author><author><name sortKey="Avina Zubieta, Ja" uniqKey="Avina Zubieta J">JA Avina-Zubieta</name></author><author><name sortKey="Sayre, Ec" uniqKey="Sayre E">EC Sayre</name></author><author><name 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sort="Michaud, Kaleb" uniqKey="Michaud K" first="Kaleb" last="Michaud">Kaleb Michaud</name><name sortKey="Pedro, Sofia" sort="Pedro, Sofia" uniqKey="Pedro S" first="Sofia" last="Pedro">Sofia Pedro</name><name sortKey="Schumacher, Rebecca" sort="Schumacher, Rebecca" uniqKey="Schumacher R" first="Rebecca" last="Schumacher">Rebecca Schumacher</name><name sortKey="Simon, Teresa A" sort="Simon, Teresa A" uniqKey="Simon T" first="Teresa A." last="Simon">Teresa A. 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